Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood and on exhaled volatile organic compounds (VOC) in the breath associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

Official Title

A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)

Keywords

Hypertension, Pulmonary Hypertension ReCIVA® Breath Sampler and CASPER air supply unit

Eligibility

You can join if…

Open to people ages 18 years and up

  • Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories
  • Medically stable on the basis of physical examination, medical history and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Must sign an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Must sign a separate ICF (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid [DNA]) sample for research (where local regulations permit). Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study

You CAN'T join if...

  • Participants requiring renal dialysis
  • History of lung or heart transplant (waiting list status or consideration of enlisting is allowed)
  • Participants unable to breathe room air without supplemental oxygen for at least 10 minutes (for breath collection)
  • Severe left ventricular dysfunction: Left ventricular ejection function less then (<) 35 percent (%)
  • Participants who are immunocompromised

Locations

  • UCSF not yet accepting patients
    San Francisco California 94143 United States
  • Stanford Hospital and Clinics not yet accepting patients
    Stanford California 94305 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04193046
Phase
Phase 1
Study Type
Interventional
Last Updated